The present invention relates to a method and a surgically-implanted device for providing urinary continence.
Lack of urinary sphincter control represents a major medical problem with widespread economic and social ramifications. Significant psychiatric problems frequently accompany this syndrome with the patients withdrawing from society. In addition, serious skin reactions and other hygienic difficulties result from urinary incontinence.
Incontinence may be caused by any of several factors, including: surgical scarring, severe pelvic trauma, congenital anatomic disorders, congenital or acquired neurogenic disorders, psychogenic causes, pharmacologic causes, radiotherapy to the pelvis and carcinoma of the prostrate. Various methods and devices have been developed for the treatment of incontinence. In some cases, pharmacologic agents are effective in treating incontinence. Nerve stimulation has also been found to be effective in treating some forms of incontinence. Many cases, however, require surgery either to reconstruct the urethra or to implant a prosthesis for urinary continence.
One of the more effective treatments for urinary incontinence has been the artificial, inflatable urinary sphincter. The artificial, inflatable urinary sphincter generally comprises an inflatable cuff, a fluid reservoir and a pump. The artificial sphincter is surgically implanted so that the cuff surrounds the bulbar urethra and the pump is placed in an accessible location such as the scrotum. The cuff is normally filled with fluid so as to constrict the bulbar urethra and prevent the bladder from emptying. When the user wishes to empty his or her bladder, the pump is squeezed, which forces fluid out of the cuff and into the reservoir, thereby deflating the cuff and opening the urethra.
Although effective, the artificial, inflatable urinary sphincter has some serious shortcomings. The main difficulty with such a sphincter is that the constant encircling pressure applied to the bulbar urethra results in unacceptable urethra erosion and scarring because the sphincter encircles the urethra and substantially restricts blood flow therein. After several years of use, such a sphincter may result in severe damage to the urethra.